a study of pm8002 plus nab-paclitaxel as first line therapy for tnbc

Conditions: TNBC

Summary: here, the investigators present the results from a phase ib/ii study of pm8002 in combination with nab-paclitaxel in subjects with locally advanced or metastatic triple negative breast cancer without previous systematic treatment.

pd-l1 and vegf play important roles in immune escape and tumor angiogenesis and enhance cancer growth and metastasis. pm8002 is a bispecific antibody targeting pd-l1 and vegf-a. here, the investigators present the results from a phase ib/ii study of pm8002 in combination with nab-paclitaxel in subjects with locally advanced or metastatic triple negative breast cancer without previous systematic treatment.

Eligibility criteria:
inclusion criteria: 1. voluntarily participate in clinical research; fully understand the study and voluntarily sign the informed consent; willing to follow and have the ability to complete all trial procedures; 2. male or female, aged 18 to 75 years (including boundary value); 3. unresectable locally advanced or metastatic breast cancer confirmed by histology or cytology, er, pr, her-2 are all negative. negative er and pr were defined as: ihcer \< 1%, ihcpr \< 1%. her-2 negative is defined as: ihcher-2 (-) or (1+), her-2 (2+) must be tested by fish and the result is negative. 4. patients who have not received systemic treatment for advanced tnbc in the past are allowed to use taxane anti-tumor therapy in the previous neoadjuvant and/or adjuvant treatment stage, but must meet the end time of taxane neoadjuvant and/or adjuvant treatment recurrence/metastasis interval ≥ 12 months; 5. sufficient organ function; 6. the eastern cooperative oncology group (ecog) score of physical status is 0-1; 7. expected survival period ≥ 12 weeks; 8. according to the recist1.1 standard, the subject has at least one measurable tumor lesion. exclusion criteria: 1. history of severe allergic diseases, allergic history of serious drugs (including unlisted test drugs) or known allergic to any component of this test drug; 2. previously received any antibody or inhibitor therapy targeting pd-1/pd-l1 or vegf; 3. there is meningeal metastasis, uncontrollable or symptomatic central nervous system (cns) metastasis; 4. those who have active infection and currently need intravenous anti-infection treatment; 5. at present, there are uncontrollable pleural effusion, pericardium effusion and abdominal effusion; 6. before the start of the study and treatment, fever of unknown cause \> 38.5°c (according to the researcher's judgment, fever caused by tumor can be included in the group); 7. known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 8. known history of alcohol abuse, psychotropic substance abuse or drug abuse; 9. have a clear history of neurological or mental disorders, such as epilepsy, dementia and schizophrenia; 10. human immunodeficiency virus (hiv) infection or known acquired immunodeficiency syndrome (aids); 11. syphilis nonspecific antibody test is positive (such as trust and prp) or syphilis specific antibody test is positive (such as tppa) \[it is acceptable that "syphilis specific antibody test" is positive but "syphilis nonspecific antibody test" is negative for more than one year\]; 12. active tuberculosis, or a history of tuberculosis infection in the past but failed to control after treatment; 13. active hepatitis b (hbsag positive and hbv-dna ≥1 1000 iu/ml) can be controlled by antiviral drugs (hbv-dna \ detection limit of research center); 14. according to the researcher's judgment, the subject's basic illness may increase the risk of receiving the study drug, or confuse the explanation of the toxic reaction and ae; 15. it is expected that any other form of anti-tumor drug treatment will be required during the study; 16. women who are pregnant or breastfeeding.

Keywords: first line